The purpose of the study is to determine whether daily, high-dose administration of l-glutamine can reduce numbness and tingling caused by a taxane chemotherapy in patients with breast cancer.
L-glutamine has previously been shown to help reduce the incidence of numbness and tingling in patients with breast cancer who are receiving taxane chemotherapies. However, no study to date looks at the effect of l-glutamine given after this numbness and tingling (called 'perihperhal neuropathy') has already occurred. We hypothesize that administration of this amino acid in l-glutamine naïve patients will result in a measureable reduction of their taxane-induced neuropathy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
10,000mg by mouth, twice daily for nine weeks (± 7 days) with one permitted dose escalation to a maximum of 10,000mg by mouth three times daily.
Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9
Time frame: nine weeks
Assess Quality of Life
* Motor neuropathy as measured by the EORTC QLQ-CIPN20 at baseline and week 9 * Autonomic symptoms and functioning as measured by the EORTC QLQ-CIPN20 at baseline and week 9 * Overall quality of life as measured by the EORTC-30 questionnaire at baseline, 3 weeks, 6 weeks, and week 9 * Pain severity as measured by the Visual Analog Numeric Pain Scale at baseline, week 3, week 6 and week 9 * Objective assessment performed by Physical Therapy Department as measured by the Functional Gait Assessment at baseline and week 9 * Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and evaluated through clinical assessment by NCI CTCAE v3.0
Time frame: nine weeks
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